Circadian Timing, Information Processing and Energy Balance Study (TIME)

Circadian and Sleep Pathways to Cardiometabolic Disease Risk: Role of Neurobehavioral Processes

This study design will test biological and behavioral mechanisms in the cross-sectional analyses and determine the prospective effects of circadian alignment and sleep on changes in cardiometabolic risk factors.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity

Detailed Description

The goal of this study is to determine how sleep and circadian rhythm alignment contribute to neurobehavioral and behavioral mechanisms of cardiometabolic risk. The investigators propose that circadian misalignment, which is more common among individuals with late sleep timing, leads to increased consumption of energy dense/prepared foods and to decreased insulin sensitivity. Short sleep duration and neurobehavioral measures (i.e. delay discounting) may moderate these associations, thus exacerbating cardiometabolic risk factors. There is evidence for a direct biological link between circadian misalignment and insulin resistance, and for a relationship that is mediated through changes in eating behaviors. Insulin resistance and increased caloric intake over time lead to increased BMI and body fat.

In this study, the investigators will conduct cross-sectional and longitudinal analyses to determine biological and behavioral mechanisms that link circadian alignment and sleep duration to changes in cardiometabolic risk over 1 year. This study will identify individual differences that predict risk for cardiometabolic disorders and suggest potential for sleep, circadian and neurobehavioral interventions to reduce cardiometabolic risk.

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

• Demonstrate habitual sleep onset time between 10:00 pm-3:00 am on actigraphy;
• able to read and write in English;
• BMI 25-39.9 (overweight, class one obesity, or class two obesity)

Exclusion Criteria:

• High risk or presence of sleep disorders (obstructive sleep apnea (OSA), restless legs syndrome, or insomnia) as assessed by the questionnaires and overnight OSA screening;
• Diagnosed with diabetes or HbA1c>7 at screening or taking medications known to affect glucose;
• History of cognitive or neurological disorders;
• Presence of major psychiatric disorders, current alcohol or substance abuse as determined by screening questionnaires or self-report;
• Unstable or serious medical illness;
• Overnight shift work or travel over 2 time zones in the past 2 months;
• Use of hypnotic, stimulant or medications know to affect melatonin concentrations such as beta blockers, daily NSAIDs;
• Current smoking;
• Daily caffeine intake >300 mg;
• Pregnant or lactating;
• Currently on a restrictive of special diet.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study participants; 18-60 year olds who demonstrate habitual sleep onset time between 10:00 pm-3:00 am and BMI 25-39.9.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin resistance	Measured by a frequently sampled IV glucose tolerance test	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating behaviors	Healthy Eating Index will be calculated from the Automated Self-Assessment of 24 hour diet recall (ASA-24)	12 months
Delay discounting	Measured by a 10 item adjusting delay discounting measure	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Height and weight will be measured at screening and 1 year follow-up	12 months
Metabolic control	HbA1c will be measured at screening and 12-month follow-up	12 months

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Illinois at Chicago; Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: February 13, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 00117438; 1R01HL141706-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon request
• IPD Sharing Time Frame: Data will be available within 1 year of completion of the study and will be available for 1 year
• IPD Sharing Access Criteria: Written request to the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No